The first generation of cell therapy developers had to face their own special challenge: cytokine release storm. But now that that hurdle has largely been cleared, the next wave of cell therapies in the clinic are running smack dab into a whole new set of safety issues that have triggered an array of clinical holds in the field. Just what is going wrong here and what can scientists do to get past this threat?
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The money tree on Wall Street has withered badly for biotech this year. After a long running boom, generalists are out of here — for now — leaving high risk, high reward plays like biotech high and dry. So it’s time for more careful planning, and that can mean prioritizing the pipeline, looking at cutting the fat without touching the bone and muscle and generally doing a lot better job of managing the burn rate as you steer to a galaxy of catalysts. And we have some of the industry’s top advisors on hand to provide some insights, as well as answer your questions.
Getting more patients — as well as a more diverse group — to participate in clinical trials has been a hot topic for years now, and some proponents have been urging regulators to modernize how drug developers are allowed to conduct clinical trials. Endpoints News regulatory expert Zachary Brennan will gather a panel of experts together to examine just how this should be done. This is a must-watch panel for anyone interested in drug development.
Senior editor Beth Snyder Bulik is bringing together some of the top execs from biotechs that have made the big leap from development to marketing their own drugs. What does it take to compete with the big established players in pharma? And what are the most common pitfalls in making the transition? If you’re considering a first-time launch – or just curious about how they did it – you won’t want to miss this one.
Now that the CRISPR revolution has taken hold, academic scientists and biotechs are expanding the notion of what’s possible with new tools to edit the genome. Bayer, Moderna, Vertex, and other industry leaders have declared the field as a key driver for their future pipelines. We’ll be taking an in-depth look with Metagenomi's CEO and co-founder, Brian C. Thomas, and other thought leaders in the space at how to forge a path for safe and efficacious gene editing therapeutics and the future of enabling technologies that will make this possible. Furthermore, we will focus on the financial and business endeavors that will ultimately make way for breakthroughs in gene editing to benefit patients.